NCT02371096

Brief Summary

Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

First QC Date

February 5, 2015

Last Update Submit

February 19, 2015

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Area under the serum concentration versus time curve (AUC)

    0-24 weeks

Study Arms (2)

RGB-03

EXPERIMENTAL
Drug: RGB-03

MabThera (rituximab)

ACTIVE COMPARATOR
Drug: MabThera (rituximab)

Interventions

MabThera (rituximab)DRUG
MabThera (rituximab)
RGB-03DRUG
RGB-03

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active Rheumatoid Arthritis
  • Inadequate response or intolerance to other DMARDs and anti-TNFs
  • Treatment with Methotrexate

You may not qualify if:

  • Previous treatment with rituximab
  • Patients with systemic manifestations of rheumatoid arthritis
  • Patients seropositive for HIV, HCV, HBV
  • Female patients nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 25, 2015

Primary Completion

June 1, 2016

Last Updated

February 25, 2015

Record last verified: 2015-02